Abbott Senior Regulatory Affairs Specialist in Pleasanton, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Develops domestic and/or international strategies for regulatory approval of company products.
Coordinates, compiles and submits U.S, and/ or International regulatory submissions, including filing and/or creation of PMAs, IDEs, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.
Prepares robust regulatory applications to achieve departmental and organizational objectives.
Represents RA on cross-functional product development and manufacturing support teams. Guide teams to provide content for US and/or International submissions, participates in design reviews as needed.
Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
Interfaces directly with U.S. Food and Drug Administration (FDA) and other regulatory agencies.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Reviews protocols and reports to support regulatory submissions. Creates, reviews and approves engineering change orders.
Communicates with and maintain productive, constructive relationships with external customers as required – US FDA, Health Canada, regulatory representatives, and notified-bodies.
Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with FDA and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Provides mentoring and leadership to Regulatory Specialist I and II team members.
Performs other related duties and responsibilities, on occasion, as assigned.
BA or BS degree in life sciences or engineering, or other technical discipline, is required.
A minimum of 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry.
Experience with, PMA supplements, 510(k) applications and US device regulations and/or experience with EU and other international medical device regulations and submissions.
Must be familiar with relevant US/international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
Experience with word processing, spreadsheet and presentation graphic software packages is required.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 5%, including internationally.
Ability to maintain regular and predictable attendance.
Ability to identify and solve problems and work independently with little oversight.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com